Creating Documents from an EDL Item (Recommended)
Creating documents from an EDL Item is recommended — the system carries over fields such as Study and Classification, which maximizes matching success:
- Open the study → Expected Documents list, choose an entry (e.g. a Protocol entry), and open its detail page to check Document Type / Classification, # Expected, Completeness.
- All Actions → Create Document.
- Choose a creation method (see below), fill in the Name (e.g.
EXP-Protocol-v1), verify Study and Document Type / Classification were carried over, upload the PDF, and save.
The document is created in the In Progress state at version ~0.1.
Three Creation Methods
| Method | Description | Use when |
|---|---|---|
| Upload | Upload a source file (PDF etc.) | Regular case with an existing file |
| Placeholder | Create a document without a file | The file is not ready yet |
| From Template | Create from a document template | The document type has an available template |
Note
Creating from an EDL Item only pre-fills fields; the match relationship is established automatically after the document is saved (see matching rules in EDL & Expected Documents).
Creating from the Document Library (Alternative)
If you don't use the EDL Item entry point:
- Open Documents (the library) → Create.
- Manually fill in Study and Document Type / Classification (must match the target EDL Item).
- Upload the file and save.
Field alignment is the key to matching when creating manually: a match is established only when all configured matching fields agree.
What Happens After Saving
- The document enters a controlled lifecycle (In Progress) and can be submitted for review (see Review & Approval).
- The system automatically matches relevant EDL Items; results appear in each entry's Matched Documents section.
- Approved documents whose classification maps to the reference model are automatically filed into Master File Binders (see TMF Viewer & Master File Binders).
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Create Document is missing | Verify the account has expected-document action permissions and the entry is Active |
| Matched Documents is empty | Verify the document's Study, Classification etc. match the EDL Item; wait a few seconds and refresh, or run Match Documents |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Document: Create, Edit | Uploading source files, saving documents |
| Object action | EDL Item: Create Document | Creating from an expected document entry (recommended path) |
| Object | EDL Item: Read | Viewing entry details and Matched Documents |
Document Contributor has all of the above. Read-only roles can browse the document library but cannot create or upload.